Kornimate/medical-research-clean huggingface dataset:
coaching dementia caregivers to master care-resistant behavior

Conditions: Care-resistant Behavior; Dementia

Summary: 266 family caregivers will be randomly assigned to either immediate intervention or delayed intervention groups. all caregivers will complete baseline surveys and 3 weeks of daily diaries. the immediate intervention group will receive 12 weeks of curb-it. they will complete 3 rounds of 3-week daily diaries followed by an intermittent survey at 12 week intervals for the next 33 weeks. the delayed intervention group will receive 12 weeks of attention, complete 1 round of 3-week daily diaries followed by an intermittent survey, then complete 12 weeks of curb-it, and complete 2 rounds of 3--week daily diaries followed by an intermittent survey at 12-week intervals for the next 18 weeks.

the purposes of the delayed-intervention randomized clinical trial (n=266) are to: care-resistant behavior internet training (curb-it). 1. examine the efficacy of curb-it in increasing the self-efficacy of family caregivers of persons living with dementia to handle care-resistant behaviors (crb); 2. further test the efficacy of curb-it in improving caregivers coping strategies (a) among the experimental (immediate-intervention group) as compared to the control (delayed-intervention group) (between groups) and (b) within-person from pre- to post- intervention; 3. examine intervention decay at 3- and 6-months post intervention to determine performance of intervention and inform scheduling of booster sessions; 4. assess the efficacy of the curb-it intervention in preventing onset of poor coping strategies by family caregivers; 5. test the hypothesized mechanism of action that increased crb self-efficacy and use of curb-it problem-focused coping strategies mediate the relationship between crb stress appraisal and caregiving activities.

Eligibility criteria:
inclusion criteria: * 1)caregiver of any race or gender who is aged \>18 years * 2) provides unpaid care, * 3) cares for a spouse/common-law, sibling, parent or grandparent (or in-law, aged 60+ years), * 4) lives with or shares cooking facilities with the care recipient, * 5) care recipient has mild cognitive impairment or dementia as identified using the quick dementia rating system instrument, * 6) the care provided consists of help with at least 2 instrumental activities of daily living or one activity of daily living, * 7) the care recipient is resistant to receiving assistance with, or refuses to do, at least one instrumental or activity of daily living exclusion criteria: * 1) persons who cannot speak/read english * 2) who do not have reliable access to a smart phone or internet

Keywords: dementia care-resistant behavior caregiver coping
study to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-vegf) treatment regimens in patients with wet age-related macular degeneration

Conditions: Macular Degeneration

Summary: retrospective, non-interventional, observational multi-center field study. patients diagnosed with wet age-related macular degeneration (wamd) and having started treatment with ranibizumab between january 1, 2009 and december 31, 2009 must be consecutively screened and, if eligible, enrolled. patients will be followed up at maximum until december 31, 2011. switch to any other anti vascular endothelial growth factor (anti vegf) treatment will be documented. for each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.


Eligibility criteria:
inclusion criteria: * diagnosis of wet age-related macular degeneration * start of anti-vegf therapy with ranibizumab (lucentis) between january 1, 2009 and december 31, 2009 * informed consent form signed exclusion criteria: - participation in an investigational study during anti-vegf therapy (from start up to december 31, 2011) that involved treatment with any drug or device

Keywords: wamd anti-vegf
lipids of the human tear film and their effect on tear stability

Conditions: Blepharitis

Summary: this prospective, randomized, comparative clinical trial evaluates the effect of either oral doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.

subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline or topical azithromycin solution. doxycycline is dosed at 100 mg bid; topical azithromycin is delivered once per day as a 1% solution. treatment with doxycycline is for two months; treatment with topical azithromycin is for one month. following treatment, meibomian glands are again expressed and the lipids measured by spectroscopy (ftir, maldi-tof, nmr)for characterization of structure and function. analysis for presence of doxcycline or azithromycin is also performed. changes in lipid parameters are correlated with clinical signs and symptoms of disease.

Eligibility criteria:
inclusion criteria: * meibomian gland dysfunction exclusion criteria: * lid margin scarring; herpetic blepharitis

Keywords: meibomian gland dysfunction lid margin disease doxycycline azithromycin essential fatty acid
short, simple, exercise to improve circadian dependent postprandial glycemic responses

Conditions: Postprandial Glycemic Response; Postprandial Hyperglycemia; Postprandial Insulin

Summary: the goal of this clinical trial is to test whether one minute of stair stepping at a comfortable pace can reduce blood sugar after meals. the main objectives of the study are: compare continuously measured post-meal glucose after stair-stepping to control condition compare continuously measured post-meal glucose after stair-stepping between meals assess interaction between condition and meal to determine if the effect of stair-stepping on post-meal glucose depends on meal participants will be in the study for 10 days and will be asked to: wear a continuous glucose monitor over the course of the study perform either one minute of comfortable pace stair stepping 15 min after each meal or no exercise 1 hour after eating a meal on alternating days perform a dietary recall every two days perform no exercise within one hour after each meal on any day during the study consume no calories within one hour after each meal during the study

after being informed about the study and potential risks, all participants giving written informed consent will undergo a screening to determine eligibility for study entry. at day 1, patients who meet the eligibility requirements will be randomly assigned to arm 1(stair stepping day followed by no exercise day sequence) or arm 2(no exercise day followed by stair stepping day sequence). at this time participants will also be familiarized with the continuous glucose (i.e., blood sugar) monitor they will wear for ten days, be instructed how to fill out a food log every day and determine a comfortable stair stepping pace. on day 10 participants will return to the lab for sensor removal and transmitter return.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years * able to climb and descend stairs * access to stairs exclusion criteria: * glycemic medications that vary in dosage * dosage from meal to meal or day to day (eg insulin titrated to meal size or carbohydrate content)
improving psoriasis through health and well-being

Conditions: Psoriasis

Summary: the purpose of the study is to examine and compare the effects of the mindfulness-based stress reduction (mbsr) program and the living well (lw) program on adults with psoriasis in terms of how these programs may affect their psoriasis, immune function, physical and emotional health, and well-being.

the study examines the effects of two eight-week programs (mbsr vs. lw) for disease processes in patients with psoriasis severity reporting moderate or higher perceived stress. the research will focus both on clinical measures of the disease state and overall well-being. the aims of our proposed intervention study are the following: 1. to examine the effects of mbsr, versus the living well (lw) program, on (a) disease severity, immunological markers of inflammation, and keratinocyte proliferation, (b) psoriasis-related stress and perceived stress in general, and (c) anxiety and depression. 2. to examine whether treatment effects of either program are moderated by personality traits, mindfulness, and age. 3. to examine the effects of behavioral and psychological mediators on immune outcomes.

Eligibility criteria:
inclusion criteria: * age 18 and older * english speaking * clinical diagnosis of psoriasis (active at initial visit) exclusion criteria: * currently receiving immunosuppressive therapy for cancer or for diseases unrelated to psoriasis (or \< 6 months post-chemo or radiation) * major, uncorrected sensory impairments * cognitive deficits (mmse \<25, or deficits deemed significant enough to interfere) * severe cardiovascular disease * current alcohol abuse or non-alcohol psychoactive substance use disorders, psychotic disorders (current and lifetime), and current mood disorder with psychotic features.

Keywords: psoriasis mindfulness mbsr stress living well
imaging evaluation of pln-74809 in participants with ipf (pln-74809)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is a phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with pln-74809 for 12-weeks. this study is occurring at massachusetts general hospital.

this is a phase 2a, single-center, randomized, double-blinded, placebo-controlled study to evaluate type 1 collagen deposition in the lungs of participants with idiopathic pulmonary fibrosis (ipf) following once-daily (qd) treatment with 160 mg pln-74809 for 12 weeks. the study consists of an up to 28-day screening period, a 12-week treatment period, and a 2 week (±3 days) post treatment follow-up period. approximately 12 eligible participants will be randomized in a 2:1 ratio (160 mg pln-74809 vs placebo; approximately 8 receiving pln-74809 and 4 receiving placebo) on day 1 (visit 3). randomization will be stratified by use of standard of care ipf therapy with pirfenidone or nintedanib. pet/mri scans will be conducted at baseline and at week 12.

Eligibility criteria:
inclusion criteria: * participants, aged 40 years or older * diagnosis of ipf, within 8 years prior to screening * fvc % predicted ≥45%; historical fvc for entry in the study is permitted if within 1 month of screening * diffusing capacity for carbon monoxide dlco (hemoglobin-adjusted) ≥30%; historical dlco for entry in the study is permitted if within 1 month of screening * participants currently receiving treatment for ipf with nintedanib or pirfenidone are permitted, if on a stable dose for at least 3 months exclusion criteria: * currently receiving or planning to initiate treatment for ipf (fibrosis) with agents not approved for that indication by the fda * forced expiratory volume during the first seconds of the forced breath (fev1)/fvc ratio \<0.7 at screening * clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect fvc measurement or ipf progression * known acute ipf exacerbation or suspicion by the investigator of such, within 6 months of screening * smoking of any kind within 3 months of screening
effects of flaxseed supplementation in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: to evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. both groups will be advised to follow an energy balanced diet and physical activity recommendations. parameters related to metabolic syndrome will be measured at the baseline and at the end of the study.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * having three of the following five features: increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated tg (≥150 mg/dl), reduced hdl-c (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the national cholesterol education program adult treatment panel iii report exclusion criteria: * history of allergy or high consumption of nuts, flaxseed, or sesame seeds * clinically diagnosed renal, liver, heart, pituitary, thyroid, or psychiatric disorders impairing the patient's ability to provide written informed consent * history of cardiovascular diseases, cancers, alimentary tract disorders affecting absorption * pregnancy, lactation, and lack of effective birth control in women of child-bearing potential
to develop a high quality health care delivery model for the management of hypertension and diabetes at chcs and district hospitals of himachal pradesh.

Conditions: Hypertension; Type 2 Diabetes Mellitus

Summary: hypertension and diabetes are major risk factors for cardiovascular diseases. although these two conditions can be detected much early in life and are amenable to interventions at primary health care level, the health system in india fails to provide adequate interventions at primary health care level which translates to huge burden of undiagnosed and uncontrolled hypertension and diabetes in the community. this study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of himachal pradesh. the study will be conducted at the 5 community health centers (chcs) and district hospital of solan district, himachal pradesh using both qualitative and quantitative methods. the design and development of the model will be carried out in the initial six months followed by piloting the services at the chcs and district hospital. the impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.

this study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of himachal pradesh. the study will be conducted at the 5 community health centers (chcs) and district hospital of solan district, himachal pradesh using both qualitative and quantitative methods. the design and development of the model will be carried out in the initial six months followed by piloting the services at the chcs and district hospital. the impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.

Eligibility criteria:
inclusion criteria: * all consenting adults of age \>30 years attending the community health centre's and civil hospital of solan district of himachal pradesh. exclusion criteria: * person not willing to consent * \<30 years of age * history of coronary heart disease or stroke * pregnant or trying to become pregnant or of child-bearing potential and not actively practicing birth control (including natural methods) * malignancy or life-threatening diseases
effect of neck flexion on esophagogastric anastomotic leakage after mie

Conditions: Esophageal Neoplasms; Esophagectomy; Anastomotic Leak

Summary: esophageal cancer (ec) is the eighth most common cancer and the sixth leading cause of cancer deaths worldwide. minimally invasive esophagectomy (mie) is regarded as a safe and effective management for resectable ec. gastric tube is considered to be an ideal substitute for the resected esophagus, and used for cervical esophagogastric anastomoses for digestive tract reconstruction in mie. however, the tension at the anastomosed area can not be ignored and may cause cervical anastomotic leakage (cal) in some cases. continuous neck flexion is a standard post-operative posture after tracheal resection and reconstruction, and aimed to relieve the anastomotic tension. in this study, the investigators attempt to adopt the maneuver in mie, and observe its effect on relieving the anastomotic tension and decreasing the incidence of cal.

after the cervical esophagogastric anastomoses is completed and the skin incision is closed, the patient's occiput will be lifted, and then the neck will be maintained in flexing position by an assistant. the underside of the chin will be fixed to the anterior chest wall with two stout nylon sutures by the surgeon. the neck will be fixed in the neutral flexing position for 7 to 10 days after surgery.

Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus. * surgical resectable (t1-4a, n0-3, m0). * age≥18 and ≤75 years. * european clinical oncology group (ecog) performance status 0,1 or 2. * written informed consent obtain. exclusion criteria: * carcinoma of the cervical esophagus. * carcinoma of the gastro-esophageal junction (gej). * prior thoracic surgery or trauma on the right hemithorax, or previous diseases which may lead to right pleural adhesion (these patients will undergo open surgery instead of minimally invasive esophagectomy). -dysfunction of cardiorespiratory system or other surgical contraindications.

Keywords: esophageal cancer minimally invasive esophagectomy anastomotic leak neck flexion
effect of a combined exercise program on neuropathic pain and perceived quality of life in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Neuropathic Pain; Neuropathy, Diabetic

Summary: therapeutic exercise is one of the therapies used as a treatment for diabetic neuropathy, which is a complication of diabetes. in order to reduce pain and improve the perception of quality of life, a combined therapeutic exercise program will be implemented as an adjuvant and non-pharmacological treatment for diabetic neuropathy.

this is a prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest), has been approved by the research and ethics committee of the faculty of medicine of the autonomous university of yucatan, issuing a report on october 26, 2022. an identification form will be filled out that will include socio-demographic and clinical data: presence of type ii diabetes, presence of neuropathy, sex, age, marital status, schooling, occupation, bmi, time of diagnosis, hba1c, insulin use, medical treatment and a neurological examination of the extremities. the dn4 questionnaire will be used to evaluate neuropathic pain and its characteristics, the vas will be used to evaluate the degree of intensity or severity of pain, and the sf-36 questionnaire will be used to evaluate perception before and after the combined exercise program. during the intervention stage, a therapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise in the facilities of the unidad universitaria de inserción social de san josé tecoh. the duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes each, to achieve the minimum total time suggested by the guidelines of 150 minutes per week. these exercises will be prescribed in three phases to increase times, series, repetitions and resistances in a progressive manner according to the borg scale. for the analysis of the variables, the parametric student's t-test for related samples or the nonparametric wilcoxon test with significance at 95% reliability will be used. the implementation of the study can demonstrate significant improvements in the symptomatology of diabetic neuropathy, directly impacting on the perception of the quality of life of patients with type ii diabetes.

Eligibility criteria:
inclusion criteria: * patients with diabetes type 2 * patients with neuropathy * patients with medical treatment exclusion criteria: * patients with several limit function * patients with foot ulcer or amputation * patients who are involved in a exercise program already

Keywords: diabetes mellitus type 2 neuropathic pain combined exercise
a clinical trial to evaluate pf-05089771 on its own and as an add-on therapy to pregabalin (lyrica) for the treatment of pain due to diabetic peripheral neuropathy (dpn)

Conditions: Diabetic Neuropathy, Painful

Summary: the purpose of this study is to evaluate the efficacy and safety of pf-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (dpn)


Eligibility criteria:
inclusion criteria: * men and women aged 18 years to 80 years. * diagnosis of type 2 diabetes mellitlus (t2dm) with current glycosylated hemoglobin a1c (hba1c) levels of ≤ 11% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization. * presence of ongoing pain due to dpn for at least 6 months. * willing to discontinue protocol-specified prohibited pain medications for dpn throughout the duration of the study. exclusion criteria: * painful neuropathies or painful conditions other than dpn that may confound evaluation of pain due to dpn during the study. * subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy. * subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities. * pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.